Long-term effects of rivastigmine capsules in patients with traumatic brain injury

Abstract

Objective: To investigate the safety, tolerability and efficacy of rivastigmine capsules (3–12 mg/day) in a 26-week, multi-centre, open-label extension of a double-blind study.

Methods: Patients with traumatic brain injury (TBI) and persistent cognitive impairment who had received rivastigmine (3–6 mg/day) or placebo for 12 weeks could enter the extension study and receive rivastigmine (≤12 mg/day). Patients were assessed using a range of cognitive tests including the Hopkins Verbal Learning Test (HVLT) and the Cambridge Neuropsychological Test Automated Battery Rapid Visual Information Processing (CANTAB RVIP) A’ sub-test. Safety measures included monitoring of adverse events.

Results: In the extension study (n= 127), the mean duration of rivastigmine treatment was 23.8 weeks and the mean final dosage was 7.9 mg/day. Approximately 40% of patients were responders (≥1.0 SD improvement from baseline) on CANTAB RVIP A’ or HVLT total score at week 38 or endpoint. Statistically significant changes from week 12 at week 38 were observed for CANTAB-RVIP A’ and HVLT-total word recall for the sub-group of ex-placebo patients with greater severity of initial impairment. The safety profile of rivastigmine capsules was consistent with the label.

Conclusions: Treatment with rivastigmine for up to 38 weeks was safe in patients with TBI and cognitive impairment.

• traumatic brain injury
• open-label extension
• rivastigmine
• safety
• efficacy